Device Dossier

Pty Ltd - Humeral head trial prosthesis, reusable

Device Dossier for Pty Ltd - Humeral head trial prosthesis, reusable (Humeral head trial prosthesis, reusable, Class IIa, sponsor Advita Ortho AUS). ARTG…

Intended purpose

The humeral head trial is a copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary